UPDATE: FDA Warns On Severe Bone, Muscle Pain With Bone Drugs

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UPDATE: FDA Warns On Severe Bone, Muscle Pain With Bone Drugs

http://money.cnn.com/news/newsfeeds/articles/djf500/200801071616DOWJO

NESDJONLINE000451_FORTUNE5.htm

The U.S. Food and Drug Administration Monday advised doctors and

patients about the possibility of severe and sometimes

incapacitating bone, joint or muscle pain linked to popular drugs

used to treat osteoporosis and other bone-thinning diseases.

Although a discussion of severe musculoskeletal pain is included in

the prescribing information for all of the drugs, the agency

said, " the association between bisphosphonates and severe

musculoskeletal pain may be overlooked by healthcare professionals. "

The drugs - sold under several brand names including Fosamax, by

Merck & Co. ( MRK); Boniva, by Roche Holding AG (RHHBY); Zometa and

Reclast, by Novartis AG ( NVS); and Actonel, by Procter and Gamble

Co. (PG) - are known as bisphosphonates.

The FDA is conducting a separate safety review of the drugs to see

if there is a link to atrial fibrillation, a heart-rhythm disorder.

On the musculoskeletal front, the FDA said severe pain could occur

within days, months or years after starting bisphosphonate

treatment. The agency said the incidence rate of the severe pain and

risk factors for developing it are unknown.

The FDA said some patients have reported complete relief of symptoms

after discontinuing the bone-building drugs, while others have

reported incomplete or slow resolution.

The FDA said severe musculoskeletal pain is different than bone

pain, fever and chills and other problems that sometimes accompany

initial treatment with intravenous bisphosphonates or initial

exposure to once-weekly or once-monthly doses of oral

bisphosphonates. Those symptoms tend to resolve within several days

with continued drug use.

Doctors, the FDA said, need to consider whether bisphosphonate use

might be responsible for severe musculoskeletal pain in patients

taking the drugs and consider temporary or permanent discontinuation

of the drug.

In 2006, more than 37 million prescriptions were written for

bisphosphonates in the U.S., according to IMS Health, a health-care

information company; those prescriptions totaled about $4.3 billion

in sales.